DRUG
AMG 133
Solution for SC injection
Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants
Status
Completed
Phase
Phase 1
Enrollment
34
Locations
1
Results
Posted
Publications
0
Study summary
What the protocol is testing.
The primary objective of this study is to evaluate the pharmacokinetics (PK) of AMG 133 after single subcutaneous (SC) administration in healthy Japanese and Caucasian participants.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Sep 24, 2021
Study start
Sep 10, 2021
Primary completion
Apr 8, 2022
Study completion
Apr 8, 2022
Results posted
Feb 25, 2025
Registry updated
Feb 25, 2025
Outcomes
What the study measures.
Primary outcomes
Maximum Observed Plasma Concentration (Cmax) of Intact AMG 133
Time frame · Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Cmax of Total AMG 133
Time frame · Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of Intact AMG 133
Time frame · Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
AUClast of Total AMG 133
Time frame · Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Intact AMG 133
Time frame · Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
AUCinf of Total AMG 133
Time frame · Day 1 pre-dose and 24, 48, 72, 96, 120, 144, 168, 336, 504, 672, 1008, 1344, 1680, 2184, and 2856 hours post-dose
Blood samples were collected at specific times during the study for the measurement of plasma concentrations of intact and total AMG 133 by a laboratory.
Secondary outcomes
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Time frame · Day 1 to Day 120
A TEAE was defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with AMG 133 that started during or after dosing, or started prior to dosing and increased in severity after dosing. Clinically significant changes from baseline in clinical laboratory tests, 12-lead electrocardiograms (ECGs) and vital signs were also reported as TEAEs.
Number of Participants With a Positive Anti-AMG 133 Binding Antibody Result
Time frame · Days 1, 15, 29, 57 and 120
Blood samples were collected at specific times during the study for the measurement of anti-AMG 133 binding antibodies from participants who received AMG 133.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- Healthy volunteers
- Yes
Key Inclusion Criteria: 1. Healthy male or female participants between 18 and 65 years of age (inclusive) at the time of Screening (Japanese participants must be first-generation Japanese) 2. In good health, determined by no clinically significant findings from medical history, physical examination, ECG, vital signs measurements, and clinical laboratory evaluations 3. Body mass index between 18 and 30 kg/m\^2 at the time of Screening 4. Females of nonchildbearing potential Key Exclusion Criteria: 1. History or evidence, at Screening or Check-in, of clinically significant disorder, condition, or disease 2. History or current signs or symptoms of cardiovascular disease 3. History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in 4. History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance 5. Positive hepatitis B or hepatitis C panel and/or positive human immunodeficiency virus test at Screening 6. History of alcoholism or drug/chemical abuse within 1 year prior to Check-in 7. Use of tobacco- or nicotine-containing products within 6 months prior to Check-in 8. Positive test for illicit drugs, cotinine (tobacco or nicotine use), and/or alcohol use at Screening or Check-in 9. Female participants with a positive pregnancy test at Screening or Check-in 10. Female participants lactating/breastfeeding or who plans to breastfeed during the study through 90 days after the end of study (EOS) visit 11. Donation of blood from 3 months prior to Check-in, plasma from 2 weeks prior to Check-in, or platelets from 6 weeks prior to Check-in 12. Unwilling to abide with study restrictions
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
WCCT Global LLC
Cypress, California, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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